Safety and efficacy results from the INJOURNEYTM trial investigating OFEV® (nintedanib) with add-on pirfenidone provide new data to support nintedanib’s key role in IPF

Results from the INJOURNEYTM trial, investigating the use of
nintedanib in combination with pirfenidone in treating idiopathic
pulmonary fibrosis (IPF), have just been published in the American
Journal of Respiratory and Critical Care Medicine.1 The
prognosis of IPF is devastating, with 50% of patients dying within 3
years of diagnosis.2 Nintedanib is one of two antifibrotic
drugs which have been shown to slow the progression of the disease in
patients with IPF.3

INJOURNEYTM was a 12-week, open-label, randomised trial
evaluating the safety, tolerability, and pharmacokinetics of nintedanib
with add-on pirfenidone compared with nintedanib alone, in patients with
IPF.1 Change in forced vital capacity (FVC), the most
established efficacy endpoint in IPF trials, was evaluated as an
exploratory endpoint.

Although more slowly, IPF continues to progress in the majority of
patients despite effective treatment. Like other chronic diseases,
pulmonologists consider combination therapy as an attractive strategy to
further improve treatment outcomes. The scientific community has raised
the question of whether a combination of both available drugs would be
safe to use in IPF patients.2 The INJOURNEYTM
trial provides answers to these questions and is part of Boehringer
Ingelheim’s commitment to address this need. The data show that the
safety and tolerability profile of nintedanib with add-on pirfenidone is
consistent with the known profiles of the individual drugs in patients
with IPF.1

“Safety always comes first when considering the right medicine for the
treatment of an individual IPF patient. The results from INJOURNEYTM
help to close a gap on the questions of the safety, tolerability and
possible interactions of adding pirfenidone to nintedanib background
therapy in the treatment of IPF. Furthermore, the results are reassuring
and supportive of future research on combination regimens with
nintedanib in IPF,” said Professor Carlo Vancheri, Professor of
Respiratory Medicine, University of Catania, Italy and Director of the
Regional Referral Centre for Rare Lung Diseases and the Laboratory of
Experimental Respiratory Medicine.

Results from INJOURNEY™

The primary endpoint of INJOURNEYTM was the percentage of
patients with on-treatment gastrointestinal (GI) adverse events (AE)
from baseline to week 12 of randomised treatment.1 Results
show that the combination of nintedanib and pirfenidone resulted in a
manageable safety and tolerability profile in the majority of patients.1
Diarrhoea, nausea and vomiting were the most frequent adverse events,
consistent with the safety profiles of the individual drugs, with a
slightly higher incidence in the pirfenidone add-on group.1
No new safety signals were observed in combination treatment, and
serious adverse events were uncommon in both treatment groups.

Results also indicate there may be a slower decline in FVC in patients
treated with pirfenidone on the backbone of nintedanib compared with
nintedanib alone, suggesting a potential benefit of the combination.1
However, further research will be necessary to fully evaluate the
efficacy of the combination.

“We are dedicated to our research in idiopathic pulmonary fibrosis,
which is a progressive and deadly condition. Nintedanib’s long-term
impact on slowing disease progression, combined with its role in
reducing the risk of acute IPF exacerbations, make it a logical first
choice IPF treatment. These new data provide a rationale for further
research into combination regimens with nintedanib as a backbone
treatment,” said Ivan Blanarik, Senior Vice President and Head of
Therapeutic Area Respiratory, Boehringer Ingelheim.

Boehringer Ingelheim has a strong commitment to scientific research with
the goal of improving the care of people living with serious respiratory
diseases. Our vision is to change progressive fibrosing lung diseases,
such as IPF, from fatal diseases to chronic, treatable conditions, and
our research continues to evolve treatment knowledge to help transform
care for patients.

As part of our commitment, Boehringer Ingelheim is currently enrolling
patients to participate in two further clinical trials exploring the
full extent of the potential benefit of nintedanib in a broader range of
progressive fibrosing lung conditions, other than IPF - SENSCISTM
and PF-ILD*. The SENSCISTM study (Safety and Efficacy of
Nintedanib in Systemic SClerosIS) is the largest trial to date treating
patients with systemic sclerosis (also known as scleroderma) who have
also developed interstitial lung disease (SSc-ILD).4 The
PF-ILD (progressive fibrosing interstitial lung disease) trial builds on
the positive real-world clinical experience in IPF to determine whether
nintedanib can effectively treat patients suffering from other
progressive fibrosing-ILDs.5 It is the first trial in the
field of ILDs which groups patients based on commonalities in
pathophysiology and clinical behaviour of their disease, rather than the
specific diagnoses.